Kitoscell Gel 30 GRS, Correction and Restoration of Skin Injury
Description: KITOSCELL ® is a topical anti-fibrotic agent that prevents, stops, reverses and eliminates skin imperfections. It is a gel applied to the skin that acts as a specific antifibrotic agent recommended to prevent the formation of keloids and hypertrophic scars, also remove the already formed regardless of the time in which they were formed. KITOSCELL ® Gel is the original patented formula improves the appearance of the skin by minimizing abnormal scars and other imperfections in the dermis of fibrous or inflammatory origin, caused by burns, accidents, abrasions, scalds or surgeries, including: cesarean , lipectomías, laparoscopy, cholecystectomy, or cosmetic surgery of any kind, and skin changes in the environment, the sun, pregnancy or chemicals. Imperfections such as spots due to chloasma (cloth), scars [old or new], acne scars, stretch marks, wrinkles and other damage that affected the extracellular matrix of the skin decreases dramatically, in most people, generally, within six months, by applying two or three times daily KITOSCELL ® Gel. The results of several studies show that the application of two or three times a day for a minimum period of six months imperfection decreases noticeably. In most patients the apparent improvement results always occur in less than two months to apply daily. KITOSCELL ® Gel by high technology development and the action of its active ingredients is an effective and safe product, which acts as bioagent anti-TNF-a regulator of TGF-b1; appearing as a novel and safe biomodulator.
Dosage form formulation: Purified water, N-methylpyrrolidone, Macrogolglycerol hydroxystearate, 1-phenyl-5-methyl-2 (1H)-pyridone, triethanolamine, carbomer, diazolidinyl urea, iodopropinilbutilcarbamato.
Instructions: Wash the area and apply KITOSCELL ® Gel on the affected area, leaving a thin layer. Repeat this 2-3 times a day, for a minimum period of 6 months. Continue applying until no imperfection or skin disorder.
Mechanism of action: KITOSCELL ® Gel skin prevents the formation of fibrotic lesions, reduces the progression of pre-existing fibrotic scars and scars reverses firbóticas stale because KITOSCELL ® Gel has a mechanism of action: be a potent regulator specific action of pro-inflammatory human, mainly cytokines TNF-a. For its modulating action on the TGF-b-1 and PDGF that are directly responsible for cytokine proliferation and excessive activity of fibroblasts, and to this modulating action prevents the abnormal accumulation of fibrous tissue in the skin. TNF = Tumor Necrosis Factor (Tumor Necrosis Factor). = Transforming Growth Factor TGF (transforming growth factor). PDGF Platelet Derived Growth Factor = (Factor Platelet-Derived Growth). - KITOSCELL ® Gel also activates and stimulates fibroblasts produce matrix metalloproteinases (MMP's), such as elastasinasas gelatinases and collagenases, which act in the remodeling phase of scars, thereby reducing excessive fibrous tissue accumulated even in stale scars. For this production promoting activity of metalloproteases, KITOSCELL ® Gel achieves biomodulation healing, preventing and stopping the formation of fibrosis or if, reversing that excessive or abnormal fibrosis, to disappear completely fibrous imperfections, leaving the skin its natural texture. Presenting KITOSCELL ® Gel has been shown to effectively penetrate the skin to reach the deeper layers of it. Pharmacokinetic studies have shown that KITOSCELL ® Gel can easily reach the tissues when administered topically.
Due to the high technology of its unique formulation and action of its components, KITOSCELL ® Gel can cross the cell membrane without receptors or transporters. KITOSCELL ® Gel does not accumulate even administered for prolonged periods.
Contraindications: KITOSCELL ® Gel is contraindicated in patients hypersensitive to the components of the formula patients.
Restrictions on use during pregnancy and lactation: studies and trials performed with KITOSCELL ® Gel has not demonstrated teratogenic or mutagenic effect, so there are no restrictions for use during pregnancy or breastfeeding.
And Drug Interactions: To date there are no reports of any drug interactions.
Adverse reactions: KITOSCELL ® Gel is well tolerated and has minimal side effects. The incidence of adverse effects such as itching and burning is relatively low and transient (less than 2%). Occasionally data reported contact dermatitis and photosensitivity, which usually disappear frcuencia reduce or suspend the application product.
Abnormalities in laboratory test results: To date there are no reports that KITOSCELL ® alter laboratory tests.
Precautions regarding effects of carcinogenicity, mutagenicity, teratogenicity and fertility: According to the KITOSCELL ® dispobible information is not considered carcinogenic or mutagenic according to the Ames test. No data exist that could affect reproduction capacity.
Manifestations and management of overdose or accidental ingestion: No reported systemic side effects topical overdose.
Presentation: Box with tube with 30 g and 90 g.
Storage Recommendations: Store at room temperature in a cool, dry place.
Legends of protection is recommended not directly exposed to sunlight immediately after application. Do not apply to eyes. In case of contact with eyes flush with water. Keep out of reach of children.
Name and address of laboratory: Made in Mexico by Grupo Medifarma, SA de C.V.
Manufactured under license from: Cell Therapy and Technology, SA de C.V. Distributors: Cell Pharma, S. R. L. de C.V.